DEVICE: ALEUTIAN® Interbody Systems (10888857118300)
Device Identifier (DI) Information
ALEUTIAN® Interbody Systems
602-90541
In Commercial Distribution
602-90541
K2M, INC.
602-90541
In Commercial Distribution
602-90541
K2M, INC.
Trial, Size 8.5x24x16 mm, 6°
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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44759 | General internal orthopaedic fixation system implantation kit |
A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MAX | Intervertebral fusion device with bone graft, lumbar |
ODP | Intervertebral fusion device with bone graft, cervical |
MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 24 Millimeter |
Angle: 6 degree |
Width: 8.5 Millimeter |
Height: 16 Millimeter |
Device Record Status
4e433a6f-49c7-45bb-b8fb-27f2bba958a2
September 04, 2023
4
September 16, 2016
September 04, 2023
4
September 16, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(571)919-2000
mark.zellers@stryker.com
mark.zellers@stryker.com